BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNABLAST PASTE 1CC

    MDR report key: 3529711 · Received November 19, 2013

    Report

    Report Number
    3005990499-2013-00008
    Event Type
    Other
    Date Received
    November 19, 2013
    Date of Event
    September 17, 2013
    Report Date
    October 21, 2013
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NUN
    PMA / PMN Number
    K043573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CONTRACT MANUFACTURED FOR KEYSTONE DENTAL BY INTEGRA LIFESCIENCES. KEYSTONE DENTAL HAS AN EXCLUSIVE LICENSE TO SELL THE DYNABLAST PRODUCT FOR DENTAL APPLICATIONS FROM INTEGRA LIFESCIENCES, THE DEVELOPER OF THE PRODUCT. NO ADDITIONAL COMPLAINTS FROM THIS LOT WERE IDENTIFIED DURING A REVIEW OF KEYSTONE COMPLAINTS DATABASE. INTEGRA PERFORMED A DETAILED REVIEW OF THE MANUFACTURING RECORDS AND VERIFIED THAT PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE PRODUCT SPECIFICATIONS. INTEGRA'S REVIEW INCLUDED THE BATCH RECORDS, TISSUE BANK DONOR RECORD, DEMINERALIZATION RECORD, AND STERILIZATION RECORD. THERE WERE NO ANOMALIES FOUND WITHIN THESE RECORDS. A REVIEW OF THE STERILIZATION CERTIFICATE OF PROCESSING VERIFIED THAT THE PRODUCT WAS STERILIZED ON (B)(6) 2012, IN LOAD 12H02 AND WAS STERILIZED FROM DOSE 28.4 KGY TO 30.9 KGY. THE PRODUCT WAS STERILIZED WITHIN SPECIFICATION OF MIN DOSE 25.0 KGY TO MAX DOSE 35.0 KGY. STERIGENICS CERTIFIES THE MATERIALS (PRODUCTS) RECEIVED THE INDICATED DOSES WITHIN THE PRECISION AND ACCURACY OF THE DOSIMETRY SYSTEM EMPLOYED. THIS PRODUCT WAS STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF 10-6. KEYSTONE DENTAL'S INVESTIGATION DID NOT REVEAL ANY MANUFACTURING OR STERILIZATION ISSUES. THE ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. KEYSTONE DENTAL CONSIDERS THIS INVESTIGATION CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE CLINICIAN CONTACTED KEYSTONE DENTAL ON (B)(6) 2013 AND REPORTED THAT A PT COMPLAINED OF A BURNING SENSATION IMMEDIATELY AFTER PLACEMENT OF DYANBLAST PASTE. THE GRAFT WAS PLACE DONE (B)(6) /2013, AFTER IMMEDIATE EXTRACTION AT FDI-ISO DENTAL SITE 24. THE PT RETURNED FOR A ONE WEEK POST OP VISIT ON (B)(6) 2013 STILL COMPLAINING OF BURNING. EXAMINATION REVEALED THE SURROUNDING AREA WAS RED AND SORE. THE IMPLANT AND GRAFT WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599837 DYNABLAST PASTE 1CC NUN KEYSTONE DENTAL NA 120922

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention